Usability Engineering Lead

The role

You will drive usability engineering activities across product development and lead the domain within the Verification & Validation team. You will plan and document usability evaluations to ensure medical devices are safe to use.

What you will do

• Lead usability engineering activities from early concept through final verification
• Grow the domain capability and practice to become a reference for best practice
• Improve how usability engineering integrates with product development
• Build instructions, tooling, and training to support multiple development projects
• Collaborate with Product, Design, Clinical, and Engineering to integrate design feedback early
• Plan, run, and document usability evaluations following IEC 62366-1 and FDA human factors guidance
• Oversee validation of UI-related user requirements
• Oversee verification of use-related risk controls

Required qualifications

• 6+ years of experience in usability engineering or human factors for regulated medical devices
• Hands-on expertise with IEC 62366-1 usability engineering
• Experience planning and conducting formative and summative evaluations on medical devices
• Experience performing use-related risk analysis
• FDA human factors experience implementing usability engineering practices that meet FDA guidance
• Experience with regulated medical devices
• Understanding how usability and design validation evidence fit into a technical file or design history file under ISO 13485 and EU MDR
• Experience building or scaling a usability engineering practice by developing methods, tooling, or teams
• Comfortable working with both hardware and software
• Experience with medical devices that include hardware-software combinations and software-only devices (SaMD)

Nice to have

• Experience in an early-stage or fast-growing company
• Experience standing up a new practice or domain
• ISO 14971 risk management experience, specifically where use error and product risk intersect

About the company

Neko is redefining what prevention means by making data-driven, preventative care accessible through proprietary technology and direct clinical care.